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Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension (RHINO)

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ClinicalTrials.gov Identifier: NCT02220634
Recruitment Status : Terminated (PI left National Jewish Health)
First Posted : August 20, 2014
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
National Jewish Health

Brief Summary:
The purpose of this study is to see if Regadenoson may offer improved ease of use, single dose administration, and better tolerance for testing for pulmonary hypertension than iNO. You will be screened to make sure Regadenoson is safe for you with a clinical evaluation, blood tests, and an ECG.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Regadenoson Not Applicable

Detailed Description:

Pulmonary hypertension (PH) is an increase of blood pressure in the pulmonary vascular system that could cause shortness of breath, dizziness, leg swelling and heart failure. .

The diagnosis of PH requires confirmation of elevated pulmonary pressures.. Right heart catheterization (RHC) is a procedure to determine the diagnosis of PH. .

This research study is looking at the effect of intravenous infusion of the medication Regadenoson on pulmonary vasodilator response compared to the inhaled nitric oxide (iNO) response. iNO is the current standard of care practice.

The purpose of this study is to see if Regadenoson may offer improved ease of use, single dose administration, and better tolerance for testing for pulmonary hypertension than iNO. You will be screened to make sure Regadenoson is safe for you with a clinical evaluation, blood tests, and an ECG.

You will be asked to sign this informed consent form. Then, you will undergo right heart catheterization as part of your clinical care. Those who are positive for pulmonary hypertension will then undergo Regadenoson infusion and a inhaled iNO. Prior to the infusion, subjects will be asked if they have had in the last 12 hours any caffeine-containing foods or beverages, caffeine-containing medications such as theophylline 12 hours prior. Vital sign measurements will be taken to measure your heart. For those subjects that have low heart volume they will be given 500 cc of normal saline in their IV. Vital sign measurements will be taken again to make sure your heart volume is in the normal range. The doctor will administer Regadenoson 0.4 mg intravenously and this will cause your heart rate to increase. The doctor will be taking heart measurements 90 seconds, 5 minutes, 10 minutes, and 20 minutes after administration. Approximately 30 minutes after the Regadenoson has been administered you will be given iNO by facemask for 5 minutes.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension
Study Start Date : August 2014
Actual Primary Completion Date : May 25, 2017
Actual Study Completion Date : May 25, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson

Arm Intervention/treatment
Experimental: Regadenoson
Intravenous infusion of the A2A agonist regadenoson has a preferential vasodilator effect on pulmonary vasculature that is comparable to iNO, the current gold standard for pulmonary vasoreactivity studies.
Drug: Regadenoson
Injection for intravenous administration
Other Name: Lexiscan




Primary Outcome Measures :
  1. Number of people [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-75 years old
  2. Diagnosis of RHC-proven PH

    • Mean pulmonary artery pressure (mPAP) > 25 mmHg
    • Pulmonary vascular resistance (PVR) > 3 woods units
    • Pulmonary capillary wedge pressure (PCWP) < 15 mmHg).

Exclusion Criteria:

  1. Second- or third-degree AV block or sinus node dysfunction
  2. Known hypersensitivity to adenosine or regadenoson
  3. Systolic blood pressure < 90mm Hg
  4. Active bronchospasm
  5. Autonomic dysfunction as defined by prior diagnosis of:

    • Postural Orthostatic Tachycardia Syndrome (POTS)
    • Neurocardiogenic Syncope (NCS)
    • Neurally Mediated Hypotension (NMH)
    • Vasovagal Syncope
  6. Hypovolemia
  7. > 40% Left main coronary stenosis
  8. Moderate or > valvular stenosis
  9. Pericarditis/pericardial effusions
  10. > 70% carotid artery stenosis
  11. Positive urine pregnancy test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220634


Locations
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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Astellas Pharma Inc
Investigators
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Principal Investigator: Brett E Fenster, MD National Jewish Health

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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT02220634     History of Changes
Other Study ID Numbers: HS-2820
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: September 2017

Additional relevant MeSH terms:
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Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs